Full Press Release Details
Outlook Therapeutics Provides Business
Update and Reports Financial Results
for the First Quarter of Fiscal Year 2020
First clinical trial results from the
Phase 3 development program for ONS-5010 expected
CRANBURY, N.J., February 14, 2020 - Outlook
Therapeutics, Inc. (Nasdaq: OTLK) (the "Company"), a late clinical-stage biopharmaceutical company working
to develop the first FDA-approved ophthalmic formulation of bevacizumab for use in retinal indications, today announced
business highlights and financial results for its fiscal first quarter ended December 31, 2019.
"This will be an exciting year for our company as we continue
to advance towards our goal of a new BLA submission to the FDA for ONS-5010 in 2021 and, if approved, a commercial launch in 2022.
Once achieved, these milestones will allow us to move forward with our priority to provide patients with the safety and efficacy
of the first and only FDA-approved, responsibly priced ophthalmic formulation of bevacizumab," said Lawrence A. Kenyon, President,
Chief Executive Officer and Chief Financial Officer. "We are pleased to report that our Phase 3 development program for ONS-5010
continues to make progress, including ongoing patient recruitment for the NORSE 2 study, which is expected to be completed by the
end of May 2020. In addition, we plan to announce the topline data for the NORSE 1 study in August 2020."
Recent ONS-5010 Highlights
The Phase 3 clinical development program for ONS-5010 consists
of two ongoing clinical trials, NORSE 1 and NORSE 2, to evaluate ONS-5010 against ranibizumab (LUCENTIS ) for wet age-related
macular degeneration (wet AMD).
The Company expects to announce a readout of the topline results
from NORSE 1 in August 2020. The NORSE 1 study, which completed enrollment in August 2019, includes a total of 61 patients at nine
sites in Australia. The endpoint for the study is the difference in mean change from baseline visual acuity at 11 months for ONS-5010
dosed on a monthly basis compared to LUCENTIS dosed using the PIER alternative dosing regimen of three monthly doses followed by
quarterly dosing. NORSE 1 will provide initial safety and efficacy data for ONS-5010 in wet AMD patients.
The Company is currently enrolling patients in the NORSE 2 trial,
and is expected to enroll a total of approximately 220 patients at more than 40 clinical trial sites in the United States. Patients
in the trial will be treated for 11 months. In agreement with the FDA, the primary outcome of the study has been changed to a statistically
significant difference in the proportion of patients who gain at least 15 letters in the best corrected visual acuity for ONS-5010
over LUCENTIS, from the mean change in baseline in visual acuity. The new study endpoint had previously been included in NORSE
2 as the key secondary endpoint, and is a standard measure of success for the treatment of wet AMD that is expected to further
enhance the probability for a positive outcome in the trial.
In addition, the Company has received agreements from the FDA
on three Special Protocol Assessments (SPAs) for three additional registration clinical trials for its ongoing Phase 3 program
for ONS-5010. These SPAs cover the protocols for NORSE 4, a registration clinical trial to treat branch retinal vein occlusion
(BRVO), and NORSE 5 and NORSE 6, two registration clinical trials to treat diabetic macular edema (DME).
The Company intends to complete development of ONS-5010 for
submission to the FDA as a new Biologics License Application (BLA) for the treatment of wet AMD, DME and BRVO. If successful, the
ONS-5010 clinical program will support Outlook Therapeutics' plan to submit for regulatory approvals in the United States,
France, United Kingdom, Italy, Germany, Spain and Japan, as well as other countries. If approved, ONS-5010 would be the first and
only on-label ophthalmic formulation of bevacizumab for treating retinal diseases.
Recent Corporate Highlights
The Company recently announced entering into agreements with
BioLexis Pte. Ltd. (BioLexis), its largest stockholder, and MTTR, LLC (MTTR), its development partner for ONS-5010, to streamline
the Company's capital structure and regain 100% ownership of any future net profits for ONS-5010. Details of these agreements
can be found in the Company's current report on Form 8-K, which was filed with the Securities and Exchange Commission on
January 31, 2020. The Company intends to seek the requisite stockholder approvals under these agreements at its 2020 Annual Meeting
of Stockholders scheduled to be held on March 19, 2020.
The Company believes that these agreements will better align
the interests of all parties with the Company's common stockholders and support the continued development of ONS-5010.
Financial Highlights for the Fiscal First Quarter Ended December
For the fiscal first quarter ended December 31, 2019, the Company
reported a net loss attributable to common stockholders of $18.5 million, or $0.62 per basic and diluted share, compared to a net
loss attributable to common stockholders of $9.9 million, or $1.00 per basic and diluted share, for the same period last year.
For the fiscal first quarter ended December 31, 2019, the Company reported an adjusted net loss attributable to common stockholders
of $8.2 million, or $0.28 per basic and diluted share, as compared to an adjusted net loss attributable to common stockholders
of $6.9 million, or $0.70 per basic and diluted share, for the same period last year.
Adjusted net loss attributable to common stockholders in the
fiscal first quarter ended December 31, 2019 includes $0.4 million of stock-based compensation expense, $0.2 million of depreciation
and amortization, $8.1 million of loss on extinguishment of debt, a $0.2 million decrease in the fair value of warrant liability,
$0.2 million stock dividend for the Company's Series A-1 convertible preferred stock, and $1.7 million of deemed dividend
upon modification of warrants. For the first quarter of fiscal 2019, adjusted net loss attributable to common stockholders includes
$0.9 million of stock-based compensation expense, $0.8 million of depreciation and amortization, $0.5 million of non-cash interest
expense, a $1.6 million decrease in the fair value of warrant liability, $2.3 million of impairment loss on property and equipment,
and a $0.2 million stock dividend for the Company's Series A-1 convertible preferred stock.
At December 31, 2019, the Company had cash of $1.3 million,
compared to $8.0 million at September 30, 2019.
Important Additional Information Will be Filed with the SEC
This communication may be deemed to be solicitation material.
The Company intends to file a definitive proxy statement for the 2020 Annual Meeting of Stockholders with the SEC, which will be
mailed to stockholders. The Company may file other documents with the SEC in connection with the 2020 Annual Meeting and the proposed
transactions. BEFORE MAKING ANY VOTING DECISION, INVESTORS AND STOCKHOLDERS OF THE COMPANY ARE URGED TO READ THESE MATERIALS CAREFULLY
AND IN THEIR ENTIRETY BECAUSE THEY CONTAIN, OR WILL CONTAIN, IMPORTANT INFORMATION ABOUT THE COMPANY, THE PROPOSED TRANSACTIONS,
THE 2020 ANNUAL MEETING OF STOCKHOLDERS AND RELATED MATTERS. Investors and stockholders may obtain free copies of the documents
filed with the SEC through the website maintained by the SEC at www.sec.gov or at the Company's website at www.outlooktherapeutics.com.
Investors and stockholders may also obtain free copies of the documents filed by the Company with the SEC by contacting the Company
by mail at Outlook Therapeutics, Inc., 7 Clarke Drive, Cranbury, NJ 08512, Attention: Corporate Secretary. Investors and stockholders
are urged to read the proxy statement and the other relevant materials when they become available before making any voting or investment
decision with respect to the proposed transactions.
Participants in the Solicitation
Outlook Therapeutics, Inc. and its directors and executive officers
may be deemed to be participants in the solicitation of proxies from the stockholders of the Company in connection with the proposed
transactions described above. Information regarding the interests of the directors and executive officers in the proposed transactions
will be included in the proxy statement that Outlook Therapeutics, Inc. intends to file for its 2020 Annual Meeting of Stockholders.
These documents are available free of charge from the sources indicated above.
ONS-5010 is an investigational ophthalmic formulation of bevacizumab
under development to be administered as an intravitreal injection for the treatment of wet AMD and other retinal diseases. ONS-5010
is currently being evaluated in two adequate and well-controlled registration clinical trials for wet AMD (NORSE 1 and 2) and,
if successful, is expected to be submitted to the FDA as a new BLA for this ophthalmic indication. If approved, ONS-5010 would
be the first and only FDA-approved ophthalmic formulation of bevacizumab to treat retinal diseases. The Company currently intends
to commercialize ONS-5010 in both vials and single-use pre-filled syringes.
Bevacizumab is a full-length, humanized anti-VEGF (Vascular
Endothelial Growth Factor) recombinant monoclonal antibody (or mAb) that inhibits VEGF and associated angiogenic activity. With
wet AMD, abnormally high levels of VEGF are secreted in the eye. VEGF is a protein that promotes the growth of new abnormal blood
vessels. Anti-VEGF injection therapy blocks this growth. Since the advent of anti-VEGF therapy, it has become the standard of care
treatment option within the retina community globally.
About Outlook Therapeutics, Inc.
Therapeutics is a late clinical-stage biopharmaceutical company working to develop the first FDA-approved ophthalmic formulation
of bevacizumab for use in retinal indications, including wet AMD, DME and BRVO. If ONS-5010, its investigational ophthalmic formulation
of bevacizumab, is approved, Outlook Therapeutics expects to commercialize it as the first and only on-label approved ophthalmic